Senior Manager R&D - IP&SS Design Development - Mechanical

Senior Manager R&D - IP & SS Design Development - Mechanical The Impact You'll Make in this Role

• Leading a team of R&D Design Development Mechanical engineers and scientists developing products across the Vascular Access Solutions, Assurance & Monitoring Solutions, and Peri-Operative Surgical Solutions portfolios while:
  • minimizing project uncertainty as early as feasible by clearly defining scope and product requirements, aligning program timing and resources with design capability to best fit within the product portfolio, and identifying new capabilities or capacities to develop internally or acquire externally
  • developing component, subassembly, assembly, and product designs that are reliable and manufacturable
  • working in concert with IP&SS R&D Product Development to maintain effective extended team resource allocation – to achieve committed deliverables
  • identifying, planning, documenting, and executing design controls and risk management processes and procedures
  • evaluating product functionality, performance, and safety through characterization, verification, and validation testing
  • continuously evaluating selected designs to ensure they meet design input requirements and performance requirements while reducing project‑, cost‑, and timeline‑risk and increasing certainty of business case attainment
  • transferring technology design knowledge to Sustaining Engineering as products enter the market; maintaining a role as technical subject matter experts to support Sustaining activities as needed
• Ensuring the health and vitality of our IP&SS new product development portfolio and products by:
  • defining and implementing vision, culture, and development focus areas for the team and our people
  • leading by example with a hands‑on, player‑coach approach
  • fortifying medical device rigor, empowering our team, driving accountability, and increasing engagement
  • developing product and technology strategies – and guiding the implementation of them – to maintain viable product portfolios while ensuring inclusion of feature, process, and technology improvements that address unmet needs and improve customer satisfaction and patient outcomes
  • contributing to organic technology‑focused ideation and feasibility activities
  • contributing to the review and due diligence of inorganic opportunities
  • leading experienced professional and/or specialist employees who exercise significant latitude and independence

• Bachelor's Degree in an applicable technical field
• Ten years of relevant experience
• Experience in a regulated industry, medical devices preferred, utilizing design controls to design, develop, verify, validate, and commercialize new products
• Previous experience managing people, leading teams, and developing/managing budgets

• Expertise in project technical leadership with the ability to oversee multiple projects simultaneously
• Experience with and working knowledge of ISO
  9000, FDA and GMP requirements including product requirements, specification documents, risk management files
• Proficiency in MS Office applications (including Word, Excel, PowerPoint), strong written and verbal communication skills, ability to read and understand technical drawings
• Strong working knowledge of processes and equipment common to medical device manufacturing; examples include additive manufacturing, machining, extrusion, injection molding, coating, adhesive and thermal bonding, die cutting, flat film converting, automated and semi‑automated manufacturing equipment
• Master's degree in an applicable technical or business field preferred
• Demonstrated ability to evaluate, mentor, and grow engineering talent
• Excellent analytical and problem‑solving skills, familiarity with statistical techniques, experience with scientific methods and Design of Experiments
• Ability to understand and resolve complex technical and business system issues

• Hybrid Eligible: requiring on‑site at Eagan, MN office at least 3 days per week

May include up to 15% domestic/international travel.

May be authorized.